Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

FDA Says Osteotech Must Improve Aseptic Processing, Investigations

The FDA issued a Form 483 to the firm following a July/August inspection of its Eatontown, New Jersey facility, where investigators found the facility’s environmental controls did not ensure aseptic processing. As a result, gram-positive bacillus was identified in several product samples.

The agency also found that the material used to stopper bottles under vacuum and for lyophilization of soft tissue was not tested for microorganisms. In addition, the employee responsible for loading the product was not monitored for microorganisms.

In addition, the FDA faulted the facility for its investigations of deviations related to current good tissue practice requirements. The company did not adequately review the causes of the deviations, the agency said. In four sterility failure investigations, the investigation did not consider all areas where contamination could have occurred, instead limiting them to the bottling room. Multiple clean corridors were omitted from the investigations even though the product moved through them during the stoppering process, the agency said.